MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC; REAMER

Device Problem No Apparent Adverse Event (3189)

Patient Problem Respiratory Distress (2045)

Event Date 04/01/2017

Event Type  Injury  

Manufacturer Narrative

Brand name, common device name, procode, mfr, lot #, part #, udi #, 510k: this report is for an unknown reamer /unknown lot.Part and lot numbers are unknown; udi number is unknown.Device evaluated by mfr, manufacture date: without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).

Event Description

This report is being filed after the review of the following journal article: hall, j.Et al (2017), prospective randomized clinical trial investigating the effect of the reamer-irrigator-aspirator on the volume of embolic load and respiratory function during intramedullary nailing of femoral shaft fractures, journal of orthopaedic trauma volume 31 number 4 pages 200¿204 (canada) doi: 10.1097/bot.0000000000000744.This prospective randomized clinical study sought to determine the incidence and volume of fat emboli during reamed im nail fixation of femoral shaft fractures treated with the reamer-irrigator-aspirator (ria) device as compared to standard reamers, as measured by intraoperative transesophageal echocardiogram (tee), blood gas parameters, and pulmonary function tests.Between may 2005 and october 2012, thirty-one patients were enrolled in this study nine were excluded because of technical difficulties with the transesophageal echocardiogram (tee) recording.Therefore a total of 22 patients (15 male and 17 female) with a mean age of 39.2 years (range, 17-69 years) and 39.2 years (range 17-64,p= 0.998) with an isolated femoral shaft fracture suitable for fixation with an antegrade im nail completed the study.Eleven (11) patients randomized to the standard reamer (sr) where a standard (sr) fluted reamers comprising with a narrow shaft and large reaming heads (smith & nephew, trigen system; styker, t2 system; synthes, synream; zimmer, sentinel) and standard statically locked intramedullary (im) nail were used.Eleven (11) patients randomized to the ria group where the reamer-irrigator-aspirator system (synthes, inc, west chester, pa) and a standard locked im nail were used.The following complications were reported as follows: group 1: (synthes, synream): 1 patient experienced a postoperative desaturation requiring reintubation and was extubated the following day.1 patient had an intraoperative desaturation requiring prolonged intubation for 4 days.3 patients experienced local irritation near proximal locking screws, which resolved with locking screw removal.(unknown manufacturer of screws).Group 2: (the reamer-irrigator-aspirator system): 1 patient had a femoral neck fracture detected and repaired intraoperatively.1 patient experienced local irritation from a proximal locking screw which was also resolved after locking screw removal (unknown manufacturer of screws).1 patient had a decrease in hemoglobin requiring transfusion on day 2 postoperatively.This report is for an unknown synthes reamer.This is report 2 of 2 for (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Device report from synthes reports an event in canada as follows: this report is being filed after the review of the following journal article: hall, j.Et al (2017), prospective randomized clinical trial investigating the effect of the reamer-irrigator-aspirator on the volume of embolic load and respiratory function during intramedullary nailing of femoral shaft fractures, journal of orthopaedic trauma volume 31 number 4 pages 200¿204 (canada) doi: 10.1097/bot.0000000000000744.This impacted product captures the following complication: group 1: (synthes, synream).1 patient experienced a postoperative desaturation requiring reintubation and was extubated the following day.1 patient had an intraoperative desaturation requiring prolonged intubation for 4 days.3 patients experienced local irritation near proximal locking screws, which resolved with locking screw removal.(unknown manufacturer of screws).

• Type of Device: REAMER
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8708087
• MDR Text Key: 148305610
• Report Number: 2939274-2019-58722
• Device Sequence Number: 1
• Product Code: HTO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/18/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention